Summary

Original source:
http://www.newsday.com/news/health/wire/sns-ap-heart-device-problem,0,4110886.story?coll=sns-ap-health-headlines

Details

• Medical device maker Guidant Corp. on Thursday stood by its decision to continue selling an implantable heart defibrillator for months after a potential flaw prompted a redesign, saying the original device was still reliable.
• "The reliability data showed that the original Ventak Prizm 2 DR, like the enhanced version, was a highly reliable life-saving product," said Steve Tragash, Guidant's director of corporate communications.
• Last week, the Indianapolis-based company told doctors that the Prizm 2 DR defibrillator had failed in a small number of cases because of an electrical flaw.
• It also said that it had fixed the flaw in devices made after mid-2002.
• But data provided by Guidant to a Minnesota hospital suggests that from May to September 2002, nine patients at Abbott Northwestern Hospital received implants of defibrillators that were made before April 2002, The New York Times reported Thursday.
• Neither instance resulted in injury to the recipient, he said.
• The Food and Drug Administration said Wednesday it was reviewing information from a meeting with Guidant to determine whether more regulatory action is warranted, The Wall Street Journal reported Thursday.
• On Wednesday, a Pennsylvania man sued Guidant, claiming the company is financially liable to all patients implanted with one of its heart defibrillators because the company did not tell them the devices could short-circuit.
• The suit filed in U.S. District Court alleges Guidant knew of the electrical problem but did not tell patients or their doctors.
• The plaintiff, John Brennan, had one of the devices implanted in his chest in April 2001.
• The suit seeks class-action status on behalf of some 24,000 patients nationwide implanted with the Ventak Prizm 2 DR model.
• Tragash said the company does not comment on pending litigation.

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